Nicole carnt, jeremy hoffman, seema verma, cherry radford, darwin c.Minassian and john k.G.Dart: acanthamoeba keratitis: confirmation of a current (b)(6) outbreak and a prospective case control study identifying contributing risk factors.(b)(4).
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On 23 march 2018, an email was received from an eye care provider (ecp).The ecp is the author of a prospective study, conducted in the (b)(6), that has been submitted for publication in 2018.The email contained an attached summary data spreadsheet containing the medical information for the subjects involved in the prospective acanthamoeba keratitis study.The information received from the ecp included only those study subject who reported wearing acuvue brand products at the time of the adverse event.All the study subjects were initially examined and diagnosed with acanthamoeba keratitis during 2011-2014.The patient (pt), study id (b)(6) , presented on (b)(6) 2013 with severe pain, photophobia, red, watery eye with poor vision in the os.The pt was diagnosed with acanthamoeba keratitis.The pt reported wearing 1 day acuvue moist brand contact lenses.The pt reported occasionally sleeping in lenses (4 nights/yr, 1 night in a row) and showering in the lenses.The pt reported the lenses were 2 months old.The pt treated was with monotherapy phmb for 3 months.Va: 6/6 (20/20) os.No additional information is expected to be received.The lot number of the suspect product is unknown.Suspect product is not available for return for evaluation.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.
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